Amgen, Inc. v. Sandoz Inc.: Divided Federal Circuit Holds that BPCIA § 262(l)(2) Information Exchange Is Optional, but § 262(l)(8) Notice of Commercial Marketing is Mandatory and Must Follow FDA Approval

Amgen, Inc. v. Sandoz Inc.: Divided Federal Circuit Holds that BPCIA § 262(l)(2) Information Exchange Is Optional, but § 262(l)(8) Notice of Commercial Marketing is Mandatory and Must Follow FDA Approval

by | Jul 21, 2015 | Featured, News

On July 21, 2015, the Federal Circuit issued an opinion addressing two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). First, the Court held that 42 U.S.C. § 262(l)(2)(A) does not require a biosimilar...

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Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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